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Fujifilm Lt-7F

by Fujifilm Corporation

Ref 04547410331615

Fujifilm Lt-7F is an invasive medical device leak tester (EU MDR Class I; FDA Class I; FDA product code FFY, Adaptor, bulbs, miscellaneous, for endoscope) made by Fujifilm Corporation, registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI 454741020100000000000565G) and listed in FDA GUDID since 7 Oct 2022 (UDI-DI 04547410331615), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number454741020100000000000565G Basic UDI-DI 04547410331615UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04547410331615 UDI-DI Date7 Oct 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 454741020100000000000565G registered 14 Oct 2026 Active
  • FDA GUDID UDI-DI 04547410331615 listed 7 Oct 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04547410331615
  2. Registered EUDAMED 454741020100000000000565G

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Air Leak Tester LT-7F EUDAMED
Fujifilm GUDID
Generic name
Invasive medical device leak tester, mechanical
Device name
Air Leak Tester 1
Model / reference
04547410331615 EUDAMED
LT-7F GUDID
Primary DI / UDI-DI
04547410331615
Basic UDI-DI
454741020100000000000565G
FDA product code
FFY
EMDN code
Z12029099 Various instruments for endoscopy and mini–invasive surgery – other
GMDN term
Invasive medical device leak tester, mechanical
Device class
Class I
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
04547410331615
GUDID
LT-7F

Related devices

Category: Invasive medical device leak tester, mechanical

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER.

Other devices from Fujifilm Corporation

See all devices from Fujifilm Corporation →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)